MAUDE Adverse Event Report: MOLNLYCKE HEALTHCARE BIOGEL SURGEONS SZ 7.5; SURGEONS GLOVE

Catalog Number 30475

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/26/2014

Event Type  Injury  

Event Description

(b)(4).Received e-mail from facility stating breakage in 45 mins of use.No sample was collected.

• Brand Name: BIOGEL SURGEONS SZ 7.5
• Type of Device: SURGEONS GLOVE
• Manufacturer (Section D): MOLNLYCKE HEALTHCARE; norcross GA
• Manufacturer Contact: jamie breadshaw ; 5550 peachtree parkway; suite 500; norcross, GA 30092 ; 6782507912
• MDR Report Key: 4121286
• MDR Text Key: 17574867
• Report Number: 3004763499-2014-00016
• Device Sequence Number: 1
• Product Code: KGO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970924
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 30475
• Device Lot Number: 14 B012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other